Outcomes of Mentalization-Based Treatment for Borderline Personality Disorder

September 25, 2017 updated by: Viktor Kaldo, Karolinska Institutet

Symptom, Alexithymia and Self-image Outcomes of Mentalization-Based Treatment for Borderline Personality Disorder: a Naturalistic Study

The effects of a psychological treatment, Mentalization-Based Treatment, was studied using a research protocol with patients with mood swings and impulsive behavior (borderline personality disorder).

Study Overview

Status

Completed

Detailed Description

Background: Mentalization-based treatment (MBT) in borderline personality disorder (BPD) has a growing evidence base, but there is a lack of effectiveness and moderator studies. The present study examined the effectiveness of MBT in a naturalistic setting and explored psychiatric and psychological moderators of outcome. Method: Borderline and general psychiatric symptoms, suicidality, self-harm, alexithymia and self-image were measured in a group of BPD patients (n=75) receiving MBT; assessments were made at baseline, and subsequently after 6, 12 and 18 months (when treatment ended). Borderline symptoms were the primary outcome variable.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • To be included, BPD diagnosis was confirmed by SCID-II interview and the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) interview, together with a consensus discussion between MBT therapists using DSM-IV and ICD-10 criteria. All patients referred between 2007-02-01 and 2012-05-30 were eligible for inclusion.

Exclusion Criteria:

  • Exclusion criteria were: IQ<85, psychotic disorder other than schizotypal personality disorder, acute/temporary psychosis, previously diagnosed autism-spectrum disorder, bipolar disorder type I and severe eating or substance use disorder.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mentalization-based Treatment
MBT was conducted according to the treatment manual developed by Bateman & Fonagy. Patients were offered individual sessions with a psychotherapist and group sessions with 6-8 participants and 1-2 group therapists for 18 months. An introductory psycho-educational component (9-12 sessions) was also offered focusing on explicit mentalising skills (i.e. understanding one's own or others' intentions). Group and individual MBT focused on implicit mentalising towards self and others.
See Arm description

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Borderline Symptoms
Time Frame: 0-18 months
Key psychiatric and borderline symptomatology as measured by the Karolinska Borderline And Symptoms Scales (KABOSS-S) was the primary outcome measure. The KABOSS-S consists of three general symptom scales (depression, anxiety, obsessive-compulsive symptoms) derived from the Comprehensive Psychopathological Self-rating Scale for Affective Syndromes and one specific borderline scale compromising the items "Mood swings", "Ability to understand own emotions", "Self-control", "Self-soothing", "Feelings of abandonment", "Feelings of emptiness", "Self-image" and "Reality Presence". Each item is scored on a Likert scale from 0 ("no presence") to 6 ("severe").
0-18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Suicidality
Time Frame: 0-18 months
Suicidality was measured by the Suicide Assessment Scale, Self-Report (SUAS-S), which covers factors known to influence suicide risk, such as affect, bodily states, control and coping, emotional reactivity, as well as suicidal thoughts and behaviour.
0-18 months
General Psychiatric Symptoms
Time Frame: 0-18 months
General psychiatric symptoms were measured using the Symptom Checklist-90 Revised (SCL-90-R), an established instrument with well-known reliability and validity.
0-18 months
Self-harm
Time Frame: 0-18 months
Self-harm was measured by the Deliberate Self-Harm Inventory-9 (DSHI-9), which has well-known reliability and validity. This measure was introduced halfway through the study period (N=42).
0-18 months
Alexithymia
Time Frame: 0-18 months
The Toronto Alexithymia Scale-20 (TAS-20) was used to measure alexithymia. It comprises 20 items divided into three subscales: Difficulty Identifying Feelings, Difficulty Expressing Feelings and Externally Oriented Thinking. TAS-20 was used to measure affective mentalization.
0-18 months
Self-image
Time Frame: 0-18 months
Self-image was assessed using Structural Analysis of Social Behavior (SASB). SASB is based on a circumplex model, measuring self-image and interpersonal interactions in relation to three interpersonal "surfaces" (i.e. actions of others, reactions to others and the introject, or what can be called the self-image. The third surface (self-image) was used, which comprises eight clusters of self-image: 1) Autonomy; 2) Self-affirmation; 3) Active self-love; 4) Self-protection; 5) Self-control; 6) Self-blame; 7) Self-attack; and 8) Self-neglect.
0-18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Viktor Kaldo, PhD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2007

Primary Completion (Actual)

May 3, 2014

Study Completion (Actual)

May 3, 2014

Study Registration Dates

First Submitted

September 14, 2017

First Submitted That Met QC Criteria

September 25, 2017

First Posted (Actual)

September 28, 2017

Study Record Updates

Last Update Posted (Actual)

September 28, 2017

Last Update Submitted That Met QC Criteria

September 25, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The dataset used and/or analysed during the current study are available from the corresponding author on reasonable request.

IPD Sharing Time Frame

1st feb 2007 - 3rd may 2014.

IPD Sharing Access Criteria

Upon reasonable request.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Borderline Personality Disorder

Clinical Trials on Mentalization-based treatment

Subscribe